Breakthrough Improvement Collaborative for ColoRectal Cancer (BIC4CRC)

NCT03320317 | Unknown DMC

• 1 other identifier: BIC4CRC/2017/1
• Study Type: observational
• Target: 950
• Locations: 1 country
• Sites: 1

Brief Summary

Colorectal cancer is the most common cancer in Europe and the third worldwide. Approximately 1 in 20 men and 1 in 35 women will develop colorectal cancer at some moment in their life. In Flanders, in 2014, there was an increase in the detection of colorectal cancer with 21% compared to 2013. Early detection improves the prognosis for the patient. In this early stage, colorectal surgery is one of the most important treatments, but it is also complex and has a high complication rate. However, over the last decade, surgical care for patients with colorectal cancer has become more standardized. The use of structured care methods, such as care pathways and protocols, has helped in standardizing care processes. Specifically for patients with colorectal cancer, perioperative care has shifted with the implementation of Enhanced Recovery After Surgery (ERAS) programs. The goal of ERAS- protocols is to optimize the interventions during the perioperative hospitalization period and reduce postoperative complications. Despite the increasing evidence in favor of the use of these standardized protocols, adherence and implementation in daily practice remains challenging. The primary goal of this quality improvement project is to enhance the standardization of key interventions in the ERAS care process for patients undergoing colorectal surgery. Therefore, adherence to the ERAS-guidelines will be investigated and hospitals will receive feedback to set up improvement initiatives. Moreover, interactive group sessions and on-site training activities will stimulate knowledge sharing and define best practices.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Number of days in the hospital

  through study completion, an average of 4 months

Secondary Outcomes (3)

• 30-days readmission rate

  through study completion, an average of 4 months

• Mortality rate

  through study completion, an average of 4 months

• Complication rate

  through study completion, an average of 4 months

Study Arms (1)

Colorectal cancer

Other: Learning session 1; Other: Learning session 2; Other: Learning session 3; Other: Learning session 4

Interventions

Learning session 1 OTHER

Learn form international report, Explain key interventions, Explain BIC methodology, Retrospective patient record analysis, Team measures

Colorectal cancer

Learning session 2 OTHER

Feedback report, Share (inter)national best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis

Colorectal cancer

Learning session 3 OTHER

Feedback report, Share best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis, Team measures

Colorectal cancer

Learning session 4 OTHER

Feedback report, Best practice symposium

Colorectal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with colorectal cancer admitted for planned surgery

You may qualify if:

• Minimum age of 18 years
• Elective admission for colorectal cancer surgery

You may not qualify if:

• Emergency (not planned) admission for colorectal cancer surgery
• Patients diagnosed with severe dementia or severe concomitant disease that may affect very short term outcome and hence influence deviations from standard acute care

Sponsors & Collaborators

• KU Leuven: lead
• Kom Op Tegen Kanker: collaborator

Study Sites (1)

KU Leuven

Leuven, Vlaams-brabant, 3000, Belgium

Location

Related Publications (2)

• van Zelm R, Janssen I, Vanhaecht K, de Buck van Overstraeten A, Panella M, Sermeus W, Coeckelberghs E. Development of a model care pathway for adults undergoing colorectal cancer surgery: Evidence-based key interventions and indicators. J Eval Clin Pract. 2018 Feb;24(1):232-239. doi: 10.1111/jep.12700. Epub 2017 Feb 1.

  PMID: 28145019 BACKGROUND

• van Zelm R, Coeckelberghs E, Sermeus W, De Buck van Overstraeten A, Weimann A, Seys D, Panella M, Vanhaecht K. Variation in care for surgical patients with colorectal cancer: protocol adherence in 12 European hospitals. Int J Colorectal Dis. 2017 Oct;32(10):1471-1478. doi: 10.1007/s00384-017-2863-z. Epub 2017 Jul 17.

  PMID: 28717841 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 13, 2017
• First Posted: October 25, 2017
• Study Start: March 30, 2018
• Primary Completion: September 30, 2020
• Study Completion: December 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

BE (1)